Job TitleDesign Quality Engineer Job Description The Design Quality Engineer is accountable for design quality, risk management, sustaining and complaint investigations for Philips Image Guided Therapy products. Your rol…
Skills: Design Assurance, Risk Management, ISO 14971, FMEA, DFMEA
Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Pr…
Skills: Inventory Management, RF Scanning, Cycle Counting, Root Cause Analysis, Training and Mentoring
Baystate Health, a nationally recognized leader in healthcare quality and safety, and home to Baystate Medical Center (BMC), and the region's only level 1 trauma center, providing services throughout western Massachusett…
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctua…
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Site: Massachusetts Eye and Ear Infirmary Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. …
Skills: Ophthalmic Testing, Vision Assessments, Diagnostic Imaging, Patient Care, Clinical Support
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our missio…
Fall River, Massachusetts, United States · On-site
$75k–$80k/yr
Mid level$23K raised
Bringing our love of food to families for five generations! Blount Fine Foods is a family-owned and operated manufacturer, marketer, and developer of premium fresh prepared foods. We are an engaging team, bringing restau…
Associate Director, Global Regulatory Lead, Oncology
Boston, Massachusetts, United States · Hybrid
$154k–$243k/yr
Senior$2.5B raised
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Global Regulatory Strategy, FDA Submissions, Oncology Drug Development, Cross-functional Leadership, Regulatory Compliance
Job Description General Summary: Vertex is a global biotechnology company that invests in scientific innovation. The Digital, Technology and Engineering (DTE) Research, Pre-Clinical, Manufacturing & Supply (RPMS) Group’s…
Skills: Solutions Architecture, Cloud Computing, AWS, Azure, Google Cloud
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Medical Content Strategy, Scientific Training, Medical Communications, Vendor Management, Budget Management
East Longmeadow, Massachusetts, United States · On-site
Entry level
Shift: Tuesday through Thursday, 3:00 PM - 11:30 PM -and- Saturday 9:00 AM - 5:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and…
Skills: Sample Preparation, Laboratory Maintenance, Documentation, Data Entry, Environmental Testing
East Longmeadow, Massachusetts, United States · On-site
Entry level
Shift: Tuesday through Friday, 3:00 PM - 11:30 PM -AND- Saturday 7:00 AM - 3:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and a…
East Longmeadow, Massachusetts, United States · On-site
Entry level
Shift: Monday through Wednesday, 1:00 PM - 11:30 PM -AND- Saturday 7:00 AM - 5:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and…
Skills: Sample Processing, Shipping And Receiving, Documentation, Database Management, Laboratory Support
Principal Robotics Engineer - Innovation (Electrical/Sensors)
Bedford, Massachusetts, United States · On-site
$117k–$167k/yr
Senior+$13M raised
Salary Range: $116,500.00 - $166,500.00 Introduction iRobot is seeking passionate and bright individuals to join our iRobot Labs innovation team within the R&D engineering organization. We are looking for a Principal Rob…
Bariatric Registered Dietitian - Center for Weight Loss Surgery
Newton, Massachusetts, United States · Hybrid
Mid level
Site: Newton-Wellesley Hospital Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-f…
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every …
Skills: MES Configuration, Recipe Authoring, Troubleshooting, System Maintenance, cGMP Compliance
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every …
Skills: MES Configuration, Recipe Authoring, Troubleshooting, System Maintenance, cGMP Compliance
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Ranked #1 for Safety, Quality and Patient Satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast. Outstanding physicians, state-of-…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$103k–$163k/yr
Full-time
bachelor degree
Paid Time Off, 401k Match, Health Savings Account, Stock Purchase Plan, Education Reimbursement
Posted 37d ago
~40 hrs/week
Responsibilities
Accountable for design quality, risk management, and complaint investigations for Image Guided Therapy products. Ensures design requirements are met through validation of key inputs and maintenance of design history files.
Requirements
Requires a Bachelor's degree in Engineering or Quality and at least 3 years of experience in FDA-regulated medical device environments. Must have proven expertise in ISO 14971, FMEA, and post-market surveillance data analysis.
Full job description
Job Title
Design Quality Engineer
Job Description
The Design Quality Engineer is accountable for design quality, risk management, sustaining and complaint investigations for Philips Image Guided Therapy products.
Your role:
Ensures that appropriate quality plans are followed with a focus on sustaining and product complaint investigations.
Provides input to design I/O process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
Provides effective input for Risk Management activities, and of all design related activities during the product/system lifecycle
Perform routine risk management updates.
Performs technical assessment on product quality performance and post-market product quality analysis.
Performs post-market data analysis/statistics to report on product quality performance in the field and to the Business on the efficacy and efficiency of the design and product realization processes.
Initiates field actions/CAPA when required.
You're the right fit if:
You have a minimum of 3+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance, Sustaining and Post Market Complaint investigations.
You have proven experience/knowledge in Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, Root Cause analysis and Defect Management.
You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.
You’re experienced in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
You’re able to share knowledge, insights regarding quality standards, and regulatory requirements.
You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
The pay range for this position in Bedford, MA is $103,000 to $163,000.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
Additional Information:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA
May require travel up to 10%.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
Related keywords
FDAMedical DeviceISO 14971FMEADFMEADesign VerificationDesign ValidationRoot Cause AnalysisDefect ManagementPost Market SurveillanceCAPADesign History FileDesign TraceabilityDesign for ReliabilityImage Guided TherapyQuality Engineering
Over the past decade we have transformed into a focused leader in health technology.
At Philips, our purpose is to improve people’s health and well-being through meaningful innovation. We aim to improve 2.5 billion lives per year by 2030, including 400 million in underserved communities.
We see healthcare as a connected whole. Helping people to live healthily and prevent disease. Giving clinicians the tools they need to make a precision diagnosis and deliver personalized treatment. Aiding the patient's recovery at home in the community. All supported by a seamless flow of data.
As a technology company, we – and our brand licensees – innovate for people with one consistent belief: there’s always a way to make life better.
Visit our website: http://www.philips.com/
Follow our social media house rules https://www.philips.com/a-w/about-philips/social-media.html
How much do Science & Research jobs in Massachusetts pay?
Based on 4337 listings with disclosed salaries, most science & research jobs in Massachusetts pay between $90k–$240k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in Massachusetts right now?
There are currently 7,032 open science & research positions in Massachusetts listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Massachusetts?
Companies currently hiring include Mass General Brigham, Sanofi, Takeda, Harvard Division of Medical Sciences, Thermo Fisher Scientific, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Massachusetts?
Yes — 2171 of the 7032 open science & research positions offer remote or hybrid work (470 remote, 1701 hybrid).
How do I apply for Science & Research jobs in Massachusetts?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.